Wilhelmina Children's Hospital, University Medical Centre Utrecht
Utrecht, Netherlands
NCT Number: NCT06562335
The goal of this experimental study is to learn if the Booster intervention can be used as an early intervention for persistent fatigue. The aim of the intervention is to prevent more fatigue-related disabilities in young people with chronic illnesses like inflammatory bowel disease, childhood cancer, and juvenile idiopathic arthritis by improving self-confidence in managing fatigue (fatigue-related self-efficacy or FSE).
The main questions this study aims to answer are:
* What is the effect of the Booster intervention on fatigue-related self-efficacy (FSE)? * What is the effect of the Booster intervention on fatigue levels, school participation, life satisfaction, and perceived health? * When does improvement in study outcomes happen relative to the Booster intervention? * What participant characteristics predict change in study outcomes?
Participants will follow the Booster intervention. Booster is a personalised, blended care intervention designed to help young people understand how their thoughts, feelings, and activities impact their fatigue using a smartphone app. The Booster app uses experience sampling methodology (ESM) to track these fluctuations. Based on insights obtained from these data, the participant and their healthcare provider can set personal lifestyle goals, such as increasing physical activity and reducing daytime naps. An earlier version of this intervention, called PROfeel, was effective in reducing severe fatigue. The investigators have now improved the app to also help with setting and achieving personal goals and monitoring daily progress.
The investigators will measure the effect of Booster through daily questionnaires during two phases: Phase A (baseline, before the goal setting between patient and healthcare provider) and Phase B (intervention, starting in the lifestyle change period). The duration of Phase A will be randomised for each participant.
Trial opening soon.
Get Notified12 year–18 year
All sexes
Interventional
Not applicable
Utrecht, Netherlands
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Regarding other treatments:
Regarding feasibility:
See description of arm. The Booster intervention has evolved from the PROfeel intervention. PROfeel is described in: https://doi.org/10.1186/s13063-022-06620-2
Other names: PROfeel
Time frame: Daily before and during the intervention, for approximately 130 days
Single-item question, self-report via Booster app. The single item was designed and validated for this study. Answered on a VAS scale 0 to 100. Higher score represents higher fatigue-related self-efficacy.
Time frame: Daily before and during the intervention, for approximately 130 days
pediatric short fatigue questionnaire, 4-item questionnaire, answered on a seven point Likert scale (1 = yes that is true, 7=no, that is not true). Total score ranges from 4 to 28, with higher scores reflecting more fatigue.
Time frame: Daily before and during the intervention, for approximately 130 days
School or work presence. Calculated: (hours present/the hours scheduled)*100
Time frame: Daily before and during the intervention, for approximately 130 days
Cantril Ladder, single-item question, rate life with ladder numbered from 0 to 10. Top of the ladder (10) represents the best possible life. The bottom (0) represents the worst possible life.
Time frame: Daily before and during the intervention, for approximately 130 days
EuroQol (EQ) visual analogue scale (VAS), ranging from 0 (worst health you can imagine) to 100 (best health you can imagine).
Time frame: Baseline, 3 months, 6 months, and if interim analysis show medium to large change also at 12 months
Self-Efficacy Scale-28 (SES-28) , 7-item questionnaire answered on a four-point likert scale, total scores range from 7 to 28 with higher scores indicating higher sense of control over fatigue.
Time frame: Baseline, 3 months, 6 months, and if interim analysis show medium to large change also at 12 months
PEDsQL-MFS, 23-item questionnaire
Time frame: Baseline, 3 months, 6 months, and if interim analysis show medium to large change also at 12 months
Pediatric Quality of Life Inventory-Multidimensional Fatigue Scale (PEDsQL-MFS), 24-item questionnaire answered on a five-point likert (0=never, 4 = almost always), total score ranging from 0 to 96, with higher scores representing more fatigue.
Time frame: Baseline, 3 months, 6 months, and if interim analysis show medium to large change also at 12 months
Pediatric Quality of Life Inventory-Generic Core Scales (PEDsQL-GCS), a 23-item questionnaire answered on a five-point likert (0=never, 4 = almost always), total score ranging from 0 to 92, with higher scores representing higher quality of life. The questionnaire has the following subscales: physical, emotional, social and school or work functioning.
Time frame: Baseline, 3 months, 6 months, and if interim analysis show medium to large change also at 12 months
Child Health Utility Index 9D (Chu9d), nine-item questionnaire answered on a five-point likert (0 to 4), total score ranging from 0 to 36, higher scores representing lower quality of life. The Chu9D has utility values that enable calculating quality adjusted life years.
Time frame: Baseline, 3 months, 6 months, and if interim analysis show medium to large change also at 12 months
EuroQol Five Dimensions Health Questionnaire Youth (EQ-5D-Y-3L), five-item questionnaire answered on a three point likert (no problems (1), some problems(2), a lot of problems(3)), total score ranging from 5 to 15, higher scores representing lower quality of life. The EQ-5D-Y-3L has utility values that enable calculating quality adjusted life years.
Time frame: Baseline, 3 months, 6 months, and if interim analysis show medium to large change also at 12 months
Single item question on average absence over past half a year in %
Time frame: Baseline, 3 months, 6 months, and if interim analysis show medium to large change also at 12 months
Illness identity questionnaire (ILQ), a 25-item questionnaire, answered on a five-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). It has the following subscales: engulfment (8 items, range 8 to 40), rejection (5 items, range 5 to 25), acceptance (5 items, range 5 to 25) and enrichment (7 items, range 7 to 35). Higher scores on subscales represent respectively higher engulfment, rejection, acceptance and enrichment. The questionnaire is adapted to specifically ask for illness identity regarding fatigue (e.g., I refuse to see my fatigue as part of myself)
Time frame: Baseline, 3 months, 6 months, and if interim analysis show medium to large change also at 12 months
Pearlin Schooler Mastery Scale, a seven-item questionnaire, answered on a four-point Likert scale, ranging from strongly disagree (1) to strongly agree (4). Total score ranges from 7 to 28, with higher scores reflecting higher levels of mastery.
Time frame: Baseline, 3 months, 6 months, and if interim analysis show medium to large change also at 12 months
Physical Activity Questionnaire for Adolescents (PAQ-A), a nine-item questionnaire. The first eight items are answered on a five-point Likert scale, ranging from low (1) to high (5) levels of physical activity. The ninth item asks whether the past week's activity was typical, less than typical, or more than typical, to provide context for the responses.The total score is calculated by averaging the scores of the first 8 items, yielding a final score ranging from 1 to 5. Higher scores indicate higher levels of physical activity.
Contact information is provided by the study sponsor or research team.
A Vroegindeweij, MSC
CONTACT
MD Stutvoet, MSC, M.D.
CONTACT
UMC Utrecht
Other
Blended Therapy for Youth With a Chronic Health Condition to Increase Fatigue-related Self-efficacy (Booster): Protocol for a Multiple Baseline Single Case Experimental Study
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